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Growth hormone trial for CF wasting halted early

NCT ID NCT00803179

Disease control Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small Phase 1 trial tested growth hormone in 5 adults with cystic fibrosis who were underweight. The goal was to see if the hormone could help them gain weight and muscle, improve their quality of life, and monitor effects on lung function and diabetes. The study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Growth hormone (somatropin)
What this could lead to
If it works, this could point toward a treatment to help people with cystic fibrosis gain weight and improve their quality of life.
What could go wrong
This is a very early, tiny trial (only 5 participants) that was terminated, so results are limited. Growth hormone may also affect blood sugar and diabetes risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Start date

Nov 2008

Finished

Mar 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study. * Age \> 18 years * Cystic fibrosis, diagnosed by either sweat chloride or genetic testing * Less than 92% ideal body weight based on body mass index (BMI) of 22 for women and 23 for men * Moderate or better pulmonary function (Forced Expiratory Volume (FEV1) \>40% of predicted). * Agree to use an effective method of birth control to prevent pregnancy during the research study. Women should not nurse (breast feed) a baby while on this study because Nutropin AQ may enter breast milk and possibly harm the child. Exclusion Criteria: * Pregnancy (positive pregnancy test) prior enrollment in the study * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial * Pediatric patients * Active neoplasm * History of organ transplantation * Prader Willi Syndrome who are severely obese or have severe respiratory impairment * Patients with hepatic impairment resulting in abnormal coagulation studies (\>1.5 times normal reference range) * Poorly controlled diabetes as determined by a Hemoglobin A1c greater than or equal to 9.0%. * Individuals with electrocardiogram abnormality or cardiac pacing.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • Umms/Ummhc

    Worcester, Massachusetts, 01655, United States

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Other studies related to the condition(s) this trial covers.